摘要
目的建立高效液相色谱法测定双氯芬酸钠凝胶的含量及有关物质。方法采用C18色谱柱（4．6mm×250mm，5μm），以甲醇-水-冰醋酸（80：20：0.8）为流动相；检测波长为276nm，流速1．0mL·min^-1结果双％芬酸钠在30～70μg·mL^-1范围内吸收度与浓度的线性关系良好，r=0．9997；平均回收率为99．88%，RSD：0．24％，3批样品的含量分别为：99．64％，99．94％，99．97％，检测限为5ng·mL^-1（S／N≈3）。有关物质为：0．087％，0．097％，0．099％。结论该法快速，简便，结果准确，适用于该制荆的质量控制。
OBJECTIVE To establish an HPLC method for determination the concent and related substances of Diclofenac Sodium in Gel. METHODS The chromatographic analysis was performed on a C18 column （4.6mm×250mm, 5μm）. The mobile phase consisted of methanol water--glacialacetic acid（80 ： 20 ： 0.8）. The detection wavelength was 276nm. The flow rate was 1.0mL · min^-1. RESULTS The Diclofenac Sodium was linear in the range of 30-70μg · mL^-1 , r =0. 9997;average recovery was 99.88%, RSD was 0. 24%, the concent of three groups were： 99.64%,99.94%.99.97%. The detection limit was 5ng· mL^-1（S/N≈3）,the related substances were：0.087%,0.097%,0.099%.CONCLUSION The method was convcn lent,rapid,accurate and reliable and so it can be used.
出处
《齐鲁药事》
2008年第10期593-595,共3页
qilu pharmaceutical affairs
